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Characters
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White or almost white powder
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Solubility
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Slight soluble in water,very slightly soluble in methanol,practically insoluble in anhydrous ethanol
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A.By IR spectrum
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Spectrum sample should be consistent with spectrum of reference standard
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B.Specific optical rotation
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Specific optical rotation(see tests)
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Appearance of solution
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The solution is clear and colorless
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Acidity
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Dissolve 0.1g in carbon dioxide-free water R.dilute to 50ml with the same solvent and add 0.5ml of phenolphthalein solution R1,Th solution is colorless.Not more than 0.6ml of 0.1M sodium hydroxide is required to chance the color of the indicator to Pink.
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Specific optical Rotation
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+74.5o to +78.0o(dried substance)
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Impurity A
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≤0.10%
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Impurity B
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≤0.10%
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Impurity C
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≤0.10%
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Any other impurity
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≤0.10%
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Total of other substances
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≤0.10%
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Total of Impurities
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≤0.30%
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Impurity D
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≤0.10%
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Loss on Drying
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≤0.50%
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Bacterial Endotoxins
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<1.0EU/mg
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Assay(dried substance)
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98.0% to 102.0%
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